CDMO/CMO Expansion Update: What Is On Tap?By
In what market segments are contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) expanding? DCAT Value Chain Insights highlights key activity in drug-substance and drug-product development and manufacturing announced thus far this year.
Chemical productions: active pharmaceutical ingredients and intermediates
AGC. AGC, a Tokyo-headquartered manufacturer of glass and chemicals, is planning an expansion of its facilities in Chiba, Japan to increase the company’s manufacturing capacity for pharmaceutical intermediates and active pharmaceutical ingredients (APIs). The new capacity, which will increase capacity at the Chiba plant by tenfold, is set to come on line in October 2019. While AGC previously mainly provided contract services for the development stage of new drugs, this expansion will give AGC the end-to-end capability to produce commercial drugs too. The new facilities will also be capable of producing highly potent APIs.
AMRI. Earlier this year (May 2018), AMRI launched a new multipurpose aseptic active pharmaceutical ingredient (API) line at the company’s facility in Valladolid, Spain. The line enhances capacity at the site while adding to AMRI’s other aseptic API manufacturing plants in Bon Encontre and Tonneins, France. AMRI says its lines are designed to meet requirements from pilot-scale to multi-ton scale manufacturing, and can be integrated with API production or operate as a separate outsourced step for customers who do not have bulk sterile facilities or who may need additional capacity. Further integration is offered with AMRI’s drug-product capabilities.
Cambrex. Cambrex, a CMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, is progressing a new $24-million facility for manufacturing highly potent APIs at its site in Charles City, Iowa. The project will also see the reconfiguration of the existing small-scale manufacturing area to provide a single high-containment building to support early-stage development and manufacturing. The facility is expected to be operational in the first half of 2019. The expansion is part of an ongoing strategic campaign by Cambrex to invest in small-molecule API development and manufacturing across its facilities and follows the opening of a $50-million, 7,500-square-foot multi-purpose manufacturing facility at Charles City in 2016, which added a total of 70 cubic meters of manufacturing capacity to the site.
The company also announced last month (September 2018) that it plans to establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina. Cambrex will acquire its currently leased 35,000-square-foot facility, as well as an adjacent 45,000-square-foot building, which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering, and analytical development laboratories. Earlier this year, the company completed a pilot-plant expansion at its facility in High Point with the installation and commissioning of a fourth reactor suite, which increased the site’s reactor capacity by around 30%. It also completed the construction and validation of a new $3.2-million, 11,000-square-foot analytical laboratory in High Point.
The company is also expanding research and development (R&D) capabilities at its site in Paullo, Milan, Italy. The company is investing to construct a new 150-square-meter R&D laboratory and recruit additional scientists to increase the number of generic APIs in the company’s development portfolio. It is estimated building work will be completed by the end of 2018, which Cambrex says will allow installation and validation of the analytical instruments to take place in the first quarter of 2019. The company is also investing $5 million to expand laboratory facilities at its site in Karlskoga, Sweden. The expansion will increase capability and capacity for process development and scale-up, handling of potent substances, crystallization studies, and solid-phase characterization. Completion is scheduled in the second quarter of 2019.
CordenPharma. CordenPharma, a contract provider of both small-molecule APIs and drug products (including solid-dosage products and sterile injectables), acquired a former Pfizer facility, a 54,000-square-foot API manufacturing facility in Boulder, Colorado with more than 100 employees, in November 2017 to build its capabilities in high-potency manufacturing. The facility, now called CordenPharma Boulder, specializes in the development, scale-up, optimization, and production of highly potent and cytotoxic/cytostatic APIs from development quantities to commercialization. The acquisition of the Boulder facility is aligned with a broader corporate strategy of offering fully integrated supply (APIs, drug products, packaging, and logistics), including a broad range of expertise in the development and manufacturing of highly potent and oncology products. CordenPharma Boulder and CordenPharma Colorado manufacture high-potency APIs. CordenPharma Plankstadt (Germany) focuses on highly potent oral solid dosage formulations, and CordenPharma Latina (Italy) is focused on oncological injectables.
Delmar Chemicals. Delmar Chemicals, a LaSalle, Quebec-headquartered manufacturer of active pharmaceutical ingredients (APIs), pharmaceutical intermediates, and other organic fine chemicals, plans to invest $45.8 million to increase production capacity of its LaSalle API plant to make it a Center of Excellence of Active Pharmaceutical Ingredients.
Dipharma. Earlier this year (May 2018), Dipharma, a Baranzate, Italy-headquartered API manufacturer, acquired Kalexsyn, a Kalamazoo, Michigan-headquartered contract research organization providing chemistry services, including custom synthesis, stable label synthesis, process impurity synthesis, and process route improvement. At the time of the announced acquisition in April 2018, Dipharma said it was planning to invest in Kalexsyn to add cGMP and highly potent active pharmaceutical ingredient capabilities in support of Phase I and early Phase II development. Design activities have begun with an anticipated ground-breaking later in 2018 with the facility expected to be fully operational by the fourth quarter of 2019.
Evonik. Evonik, a specialty and fine chemical producer, completed a EUR 36-million ($42-million) expansion of its contract manufacturing capabilities in the US and Europe. A series of technologies, including high-potency active pharmaceutical ingredients (HPAPIs), fermentation, methoxy poly(ethylene glycol) (mPEGs), and continuous processing, were introduced or enhanced at multiple Evonik production sites over the last year, the company reported in a September 18, 2018 statement.
Fermion. Fermion Oy, a Espoo, Finland-based manufacturer of small-molecule active pharmaceutical ingredients (APIs), has commissioned a new manufacturing facility in Hanko, Finland, to replace an older manufacturing unit. In 2016, Fermion announced an investment of more than EUR 30 million ($35 million) to modernize production equipment at its plant in Hanko. The investment increases the plant’s production capacity by approximately 50% up to nearly 300 tons a year.
Indena. Earlier this year, Indena, a Milan, Italy-headquartered CMO for the identification, development, and production of APIs derived from plants, opened a new kilolab for highly potent active pharmaceutical ingredients (natural, semisynthetic, and total synthetic) in Settala, Italy. Indena plans further investment in 2018 by building a new multi-purpose pilot plant, designed for grinding, extracting, and purifying toxic plants. It will also be equipped with columns for chromatographic purification and with semi- and total-synthesis capabilities.
Kaneka. Kaneka, a Tokyo-headquartered chemical manufacturing company, has installed continuous manufacturing equipment for small-molecule pharmaceutical products at Kaneka’s Singapore facility. Kaneka announced the installment in July 2018 and started commercial production using flow chemistry under GMP conditions in June 2018.
Lonza. Earlier this month (October 2018), Lonza announced the expansion of its highly potent API (HPAPI) capacity for the specific support of antibody drug conjugate (ADC) payload manufacturing. The expansion encompasses two new manufacturing suites capable of handling compounds with occupational exposure levels down to 1 ng/cubic meter. The first of the two new HPAPI suites specifically supports a global biopharmaceutical partner by securing the long-term supply of highly potent ADC payloads. The second suite will be available to other customers for similar HPAPI and payload development and manufacturing programs.
Minakem. Minakem, the CDMO division of Minafin, a Mont-Saint-Guibert, Belgium-based fine chemicals producer, has opened a new closed-controlled environment high-containment production facility at the company’s plant in Louvain-la-Neuve, Belgium. The new facility extends Minakem’s capacity to develop and manufacture highly potent APIs from small-scale development to full GMP batch releases. Operations at the new high-containment facility were scheduled to start in September 2018.
Noramco. Noramco, a CMO of active pharmaceutical ingredients for controlled substances and cannabinoids, is adding commercial-scale capacity of dronabinol (THC) at its facility in Athens, Georgia. The expansion comes in response to rising demand for its highly pure cannabidiol (CBD) and dronabinol (THC) analogs of cannabis sativa. Following implementation, Noramco will supply both THC and CBD from facilities in the US and Europe. Clinical samples will be available from the Athens site in 2018, with commercial production commencing in the first quarter of 2019. Both dronabinol in oil and dronabinol in ethanol are available in Athens. Previously, the company produced these products only in Europe.
Olon. Earlier this year, Olon S.p.A., an Italy-headquartered CDMO of active pharmaceutical ingredients (APIs) and a generics supplier, acquired a local generics chemical operations API manufacturing facility in Mahad, India as part of a continuing expansion of its global footprint. The Mahad site, which supplies products to Sandoz, the generics arm of Novartis, is an API manufacturing facility that supplies product globally. As part of the asset-purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of Sandoz products manufactured in Mahad. Olon intends to invest in the site and pursue further opportunities to optimize the plant’s use and expand its customer base. The acquisition of the Mahad API manufacturing facility is expected to be completed in early 2019, following a transition process.
Piramal Pharma Solutions. Piramal Pharma Solutions, a CDMO of APIs and drug products, is investing approximately $60 million to expand API development and manufacturing capabilities, which includes extending the high-potency API capabilities at its facility in Riverview, Michigan to meet potency requirements of up to 10 ng/cubic meters. Piramal acquired the facility as part of its acquisition of Ash Stevens, a CMO of small-molecule APIs, in 2016.
Procos. Procos SpA is progressing a GMP manufacturing unit dedicated to high-potency APIs at its facility in Cameri, Italy, located near Milan. The $21-million investment, which started in the first quarter of 2016, was scheduled for completing process-validation activity in the second quarter of 2018. The 1,200-square-meter unit includes 500 square meters of production space, 500 square meters of laboratory space, and 200 square meters of warehouse/auxiliary space. The high-potency manufacturing unit is part of a larger investment and site-expansion project of $70 million that was initiated in 2014 and that was supported by Procos’ parent company, CBC Co. Ltd. Group, a privately held company based in Tokyo.
SK biotek. Earlier this year (January 2018), SK biotek, a Seoul, South Korea-based wholly owned subsidiary of SK Holdings, set up operations at its small-molecule API manufacturing facility in Swords, Ireland, which the company had earlier acquired from Bristol-Myers Squibb. The addition of the 21-acre site adds 82 cubic meters of reactor capacity. Reactor volumes in the large-scale plants range from 4 to 7 cubic meters, and volumes in the small-scale plants range from 0.3 to 4 cubic meters of conventional space as well as 0.06 to 1.6 cubic meters for high-potency APIs. In addition, in July 2018, SK Holdings agreed to acquire Ampac Fine Chemicals (AFC), a Rancho Cordova, California-headquartered CMO of APIs and intermediates. AFC offers several specialized technologies, including production of highly potent compounds and highly energetic compounds as well as continuous processes, and industrial-scale chromatographic separation using simulated moving bed chromatography.
Sterling Pharma Solutions. Sterling Pharma Solutions, a Dudley, UK-headquartered small-molecule API CDMO, is investing £6 million ($8 million) to expand its pilot plant at its UK site to increase capacity by 33% and enhance the site’s production capabilities for small- to mid-scale batch production. The investment will add three new reactor trains at scales of 225 liters, 500 liters and 1,360 liters to meet demand for batch sizes in the 10-100 kg range as well as add a range of new capabilities to expand the company’s ability to handle potent compounds across a range of equipment scales. The facilities, based on a 40-acre site in northeast England, were scheduled to be operational by mid-2018. Sterling Pharma Solutions launched as an independent CDMO following a management buyout of the Dudley, UK site of Shasun Pharma Solutions in 2016.
WuXi AppTec. STA Pharmaceutical, a subsidiary of WuXi AppTec, signed an investment agreement in late April 2018 with the government of Shanghai, Jinshan District, China to build a new research & development center for APIs and intermediates located next to the company’s existing Jinshan drug-substance manufacturing site and will add more than 30,000 square meters of laboratory space and 500 scientists. The new campus will provide access to technology platforms such as flow chemistry, biocatalysis, and high-potency manufacturing from laboratory to commercial scale. The company’s current Jinshan site focuses on manufacturing APIs and advanced intermediates from kilo to metric ton scale.
Abzena. Earlier this year (March 2018), Abzena, a contract manufacturer of biologics and ADCs, completed a facility remodeling for a new ADC GMP manufacturing suite at its Bristol, Pennsylvania site. The facility and equipment verification and qualification for the Bristol ADC GMP manufacturing suite was scheduled for completion around the end of the second quarter of 2018. The Bristol ADC manufacturing suite adds to the company’s existing GMP manufacturing capability for the scale-up and manufacture of highly potent payload-linker constructs and the upgrading and expansion of Abzena’s biologics process development and manufacturing capabilities in San Diego, California.
AGC Biologics. AGC Biologics plans to establish a new process development and manufacturing facility in Chiba, Japan. The new facility, which is expected to be operational in the second half of 2019, will contain single-use bioreactors at the 500- and 2,000-liter scale and will be suited for producing monoclonal antibodies, fusion proteins, and other types of therapeutic proteins. The company is also increasing manufacturing capacity at its Copenhagen, Denmark facility through the addition of a single-use bioreactor “6Pack” suite, consisting of six 2,000-liter production bioreactors and a 2,000-liter seed train. The new suites are scheduled to be on line in November 2018 are expected to support the manufacturing of several commercial products. The company also reported the addition of a 2,000-liter single-use bioreactor to its Berkeley, California facility.
APC. The Applied Process Company (APC), a process development, design, and innovation company, has completed a EUR 2 million ($2.3 million) joint investment with its client partner, Bavarian Nordic A/S, a Kvistgaard, Denmark-based biopharmaceutical company, to build a new 500-liter single-use biologics facility at APC headquarters in Cherrywood, Dublin, Ireland. Since 2017, APC has been developing and testing process platforms for Bavarian Nordic A/S to provide upstream and downstream development support, scale-up, and analytical services for its broad spectrum respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV.
Avid Bioservices. Avid Bioservices, a Tustin, California-based CDMO of biopharmaceutical products derived from mammalian cell culture, is expanding its process-development capabilities and laboratory space within its campus in Orange County, California. Earlier this month (October 2018), the company initiated demolition work at the site, kicking off the latest phase in the planned expansion that will ultimately provide approximately an additional 3,000 square feet of new process-development laboratory space.The newly constructed lab space will allow for the consolidation of cell-line development, upstream process development, and upstream pilot-scale production in a single location. Plans further involve tripling the current capacity provided by the company’s benchtop bioreactor systems and hiring additional process-development scientists. The first new laboratories resulting from the planned expansion came on line earlier this year.
Brammer Bio. Brammer Bio, a Lexington, Massachusetts-headquartered cell and gene-therapy CDMO, is investing $200 million over three years to establish over 30 suites for clinical and commercial viral-vector supply for a pipeline of advanced gene therapies and gene-modified cell therapies. The investment includes expansions at Brammer’s Alachua, Florida facilities to be completed by the end of 2018 as well as expansion of its first commercial facility in Cambridge, Massachusetts, which is expected to be completed in the first half of 2019. The company is also renovating a facility at its second commercial facility, to be completed in the first half of 2019.
Cell and Gene Therapy Catapult. Cell and Gene Therapy Catapult (CGT Catapult), a center of excellence funded by Innovate UK, the UK government’s innovation agency, to support cell-therapy organizations, opened a cell- and gene-therapy manufacturing center in Stevenage, England earlier this year (April 2018). Backed by over £60 million ($83.8 million) from the UK Government investment as part of its Industrial Strategy, a long-term plan to boost productivity and earning power of people throughout the UK, the center will support and develop the cell and gene therapy industry in the UK.
Lonza. Lonza has invested CHF 400 million ($414 million) to add two new biomanufacturing services (Ibex Design and Ibex Develop) as part of its Ibex Solutions package from the company’s 100,000-square-meter biopark in Visp, Switzerland. Lonza’s first Ibex offering, Ibex Dedicate, a modular, technology-agnostic biomanufacturing concept, was launched in July 2017. Ibex Dedicate offers a facility concept with reduced capital expenditure and accelerated timelines to enable speed to market or allow biopharmaceutical companies to delay investment decisions to decrease financial risk. The two new Ibex Solutions, Ibex Design and Ibex Develop, are designed to service biotechnology companies with antibody therapies. Ibex Design and Ibex Develop will become operational from 2020 and provide manufacturing options from early development through to full commercialization. These services apply single-use and automation technologies.
Lonza is also investing in mid-scale mammalian cell biomanufacturing capacity and new cell-therapy suites at its site in Portsmouth, New Hampshire. Lonza plans to install multiple 6,000-liter bioreactors at the site with building expected to start in late 2018. Lonza is implementing full-suite process analytic technology (PAT) and advanced multi-variate analysis at the facility. The hybrid facility, which also incorporates single-use technologies, will be installed in an existing building.
In addition, Lonza is installing multiple cell-therapy suites at the Portsmouth site. In February 2018, the company established centers of excellence in cell and gene therapy across its network and placed Portsmouth as a clinical and commercial manufacturing center for cell and gene therapies. The suites will provide Phase I through to commercial manufacturing and are expected to be fully operational by late 2018. In addition, earlier this year, Lonza opened a new 300,000-square-foot dedicated cell-and-gene-therapy manufacturing facility in Pearland, Texas, part of the Greater Houston area.
Novasep. Novasep is investing EUR 27-million ($32-million) in a new commercial-scale viral-vector production facility in Seneffe, Belgium, which is scheduled to be fully qualified by the first quarter of 2019. It is also investing EUR 17 million ($20 million) in a cGMP clinical-scale monoclonal antibody production facility in Pompey, France and which is scheduled to be commissioned in the second half of 2019.
Thermo Fisher Scientific. Thermo Fisher Scientific is investing $50 million in its St. Louis, Missouri site, which is one of the company’s Centers of Excellence (COE) for Biological Commercial Manufacturing. The investment is part of a strategy to expand the company’s global network of biologic drug-substance capabilities for clinical and commercial supply. The expansion is expected to be operational in 2019.
Wacker. Wacker, a Munich, Germany-based chemical company, has expanded its biologics production facilities in Jena, Germany, with a new microbiology laboratory and equipment for process and product characterization. The company invested EUR 2.5 million ($2.9 million) in a fully automated fermentation plant, including a new bioreactor with a capacity of 350 liters, a new separator for isolating cells, and a new GMP cell-bank suite. The suite enables independent cell-bank production and expands storage capacity for customer cell banks. Also, earlier this year, Wacker acquired from SynCo Bio Luxembourg, a contract manufacturing organization, a Dutch site for manufacturing biopharmaceuticals, live microbial products, and vaccines, plus associated business.
WuXi Biologics. Earlier this year (June 2018), WuXi Biologics, part of WuXi AppTec, a Shanghai, China-headquartered contract service provider, began construction of an antibody-drug conjugate (ADC) service center in Wuxi, China. The $20-million 6,000-square-meter facility will be operational in 2019 and provide integrated services from concept to commercialization for biologics conjugates, including ADCs and other protein conjugates.
WuXi Biologics is also investing $60 million to establish a biologics clinical and commercial manufacturing facility in Worcester, Massachusetts. A total of approximately 4,500 liters of bioreactor capacity will be installed with two 2,000-liter traditional fed-batch bioreactors and one 500-liter perfusion-based bioreactor for continuous processing. This facility will be equipped to handle both clinical and small-volume commercial production. An early-stage bioprocess development lab will also be included.
WuXi Biologics is also investing 80 million Singapore dollars (US $60 million) to establish a biologics manufacturing facility in Singapore. A total of approximately 4,500-liters of bioreactor capacity will be installed consisting of two bioreactors, each with 2,000 liters of fed-batch capacity, and one bioreactor with 500 liters of perfusion-based continuous bioprocessing capacity. This facility is being designed to handle both clinical and small-volume commercial production. An early-stage bioprocess development laboratory will also be included.
In May 2018, WuXi Biologics announced plans to build an integrated biologics development, clinical, and commercial manufacturing center in Shijiazhuang, Hebei Province, North China. The initial phase of the center is expected to be operational in 2020. Additionally, in April 2018, WuXi Biologics announced plans to invest EUR 325 million ($392 million) in a new biologics drug-substance manufacturing facility in Mullagharlin, Dundalk, County Louth, Ireland.
Drug-product drug development and manufacturing
Ajinomoto Althea. Earlier this year (August 2018), Ajinomoto Althea, a San Diego, California-headquartered contract development and manufacturing organization, opened a new antibody drug conjugate and highly potent fill/finish facility near its existing campus in San Diego. The 57,000-square-foot manufacturing facility includes areas dedicated to bioconjugation, formulation, purification, quality control, and sterile fill/finish including lyophilization. The facility can accommodate early clinical phase through commercially approved programs.
Almac. Almac Group, a Craigavon, UK-based CDMO, opened a 95,000-square-foot cold-storage facility at its global headquarters in Northern Ireland earlier this year. The facility represents the completion of a £20 million ($27.5 million) investment in the company’s cold-chain-management capabilities. The new facility adds to Almac’s existing global clinical supply and drug-product capabilities. The expansion follows a recent announcement of £30 million ($41 million) investment for a new European campus based in Dundalk, Ireland. The Dundalk expansion includes a new quality-control laboratory, packaging facility for commercial drug products and a 79,000-square-foot distribution center in the European Union for clinical trial supply, all of which is scheduled to be operationally ready by January 2019.
Avara Pharmaceutical Services. Earlier this year (September 2018), Avara Pharmaceutical Services, a Norwalk, Connecticut-headquartered CDMO, acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada, as part of a continuing expansion of its global footprint.This follows Avara’s acquisition of another sterile-manufacturing facility in 2017, from Pfizer in Liscate, Italy, and its 2017 acquisition of a solid-dose manufacturing facility from GlaxoSmithKline in Aiken, South Carolina. Avara also acquired a solid dosage form manufacturing, packaging, and distribution facility in Reims, France from AstraZeneca in 2017. The latest acquisition will bring the number of manufacturing and development sites operated by Avara worldwide to 10: two in Canada; three in the US (mainland), including corporate headquarters; one in Puerto Rico; one in the UK; one in Ireland; one in Italy; and one in France.
Boehringer Ingelheim. Earlier this year, Boehringer Ingelheim completed a new filling line at its commercial manufacturing facility in Shanghai, China for its contract manufacturing business, BioXcellence. The new isolator-based fill/finish line is for GMP operations for aseptic filling of liquids in vials. The company launched the commercial production site for biopharmaceuticals in Shanghai in May 2017. The site uses mammalian cell-culture technology and supports the company’s contract biomanufacturing business.
BSP Pharmaceuticals. BSP Pharmaceuticals, a CDMO of injectables (liquid and lyo vials), nano-formulations, and oral dosage forms, initiated early this year (January 2018) a new phase of its strategic plan to sustain the continuous growth of the company that was started with the acquisition of the campus next to its current one in Latina, Italy and the construction of new buildings that will be dedicated to the manufacturing of parenterals drugs to be done in contained environments such as immuno and onco-immunotherapeutics treatments, mostly originated by biotechnology, such as monoclonal antibodies and recombinant proteins. An overall investment of approximately $150 million will be completed in three waves from 2020 to 2023. BSP was founded in 2006 to serve the anticancer market and further provides an integrated supply chain of antibody-drug conjugates by performing conjugation and fill/finish under the same site managed by the same quality system.
Cambrex. Earlier this year (September 2018), Cambrex, a contract manufacturer of small-molecule active pharmaceutical ingredients (APIs), completed its acquisition of Halo Pharma, a Whippany, New Jersey-headquartered contract development and manufacturing organization, for approximately $425 million. Cambrex announced the acquisition in July 2018. The addition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.
CapsCanada. CapsCanada, a Windsor, Ontario, Canada-headquartered provider of capsules for pharmaceuticals and dietary supplements, has invested $28 million to add a new 100,000-square-foot manufacturing facility for hydroxypropyl methylcellulose (HPMC) capsules. With this investment, CapsCanada has increased capsule output by 50%.
Catalent. Catalent Pharma Solutions has completed the first phase of a $7.3-million investment to upgrade and expand its packaging and softgel encapsulation capabilities at its facility in Aprilia, Italy. The first phase of investment, completed in August 2018, saw the expansion and upgrade of the facility’s integrated packaging capabilities, and the commissioning of the first of five new softgel encapsulation lines. The second phase of the investment, to add a further four encapsulation lines, will bring the total number of lines to 23 and expand production, drying, and inspection capacity for nutritional supplements and beauty softgels at the site. It is expected that these four new lines will be fully operational by January 2019.
Also, earlier this year, Catalent acquired Juniper Pharmaceuticals, a Boston, Massachusetts-headquartered specialty pharmaceutical company with contract development and manufacturing services, including its Nottingham, UK-based Juniper Pharma Services Division, in a deal worth $133 million. The acquisition of Juniper expands Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral-dose manufacturing and adds to its global clinical and commercial supply network.
Catalent also is investing $5 million in the creation of a new drug development center of excellence at its Somerset, New Jersey facility and headquarters.
Evonik. Evonik is investing EUR 35 million ($41 million) to expand its contract development and manufacturing (CDMO) capabilities in North America for controlled-release injectable formulations. The expansion of Evonik’s US and Canadian facilities includes the installation of a new filling line, production facilities and analytical labs. Evonik recently expanded Evonik Birmingham Laboratories, a global center of excellence for biomaterials and polymer-based injectable dosage forms in Birmingham, Alabama. The company is also constructing a new 2,900-square-meter building at its Birmingham site to expand the global production capacity of its proprietary Resomer portfolio of bioresorbable polymers. The new building is scheduled to be commissioned later this year (2018). Evonik is also upgrading an existing facility and adding a second adjacent building that will more than double the total size of Evonik Vancouver Laboratories to 4,300 square meters. Evonik acquired the Vancouver site through its 2016 acquisition of Transferra Nanosciences, a CDMO specializing in developing lipid nanoparticle-based parenteral drugs. The investments, which include the upgrade of GMP manufacturing facilities and the expansion of laboratories and scale-up services, will support new and existing customer programs.
Fujifilm Diosynth Biotechnologies. Fujifilm Diosynth Biotechnologies, a CDMO of biologic-based drugs, has extended its gene therapy and viral vaccine fill/finish capabilities to provide services in support of late-phase candidates and commercial supply. The extended fill/finish services will be provided from Fujifilm’s Flexible Biomanufacturing Facility located in College Station, Texas.
Fujifilm Toyama Chemical. Separately, Fujifilm Toyama Chemical is investing approximately 4 billion yen ($37 million) in a pharmaceutical production site to build a new manufacturing facility for liposome drugs. Construction of the new facility is expected to begin in September 2018, and the facility is scheduled to begin operations in February 2020. Fujifilm Toyama Chemical was formed, effective October 1, 2018, through the merger of Toyama Chemical, a company engaged in the research, development, manufacture and sale of small-molecule pharmaceuticals, and FujiflmRI Pharma Co., Ltd., a company engaged in the research, development, manufacture and sale of radiopharmaceuticals.
Grand River Aseptic Manufacturing. Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, earlier this year announced the expansion of its capabilities in syringe filling at its manufacturing facility in Grand Rapids. The syringe filler was scheduled to be qualified and operational by the second quarter of 2018. In addition to filling syringes, the new filler is capable of handling cartridges.
Novasep. Novasep, a Lyon, France-headquartered contract manufacturer and life-science service provider, is investing EUR 10 million ($11.8 million) in a commercial fill/finish facility for viral vectors, monoclonal antibodies and other low-volume biologics. The facility will be located in Seneffe, Belgium and will be operational in the second half of 2019.
PMI BioPharma Solutions. PMI BioPharma Solutions (PMI Bio), a CDMO formed in January of 2018, has established research and manufacturing operations at multiple sites located in Nashville and Celina, Tennessee. The sites offer services from targeted protein research to Phase III clinical trial supplies. PMI Bio’s clinical trial production capabilities include bulk liquid manufacturing, aseptic fill/finish and non-aseptic fill/finish for small to medium-scale batches. PMI Bio began as an internal research, development, and manufacturing site for Berg, LLC, a Framingham, Massachusetts-based biopharmaceutical company. PMI Bio subsequently spun off from Berg and expanded to offer a full range of research and development services for drug discovery and development.
Recipharm. In June 2018, Recipharm, a Jordbro, Sweden-based CDMO agreed to acquire Sanofi’s contract manufacturing business for respiratory products in Holmes Chapel, England for approximately $60 million. The business provides Recipharm with additional inhalation commercial drug-product manufacturing capabilities. The prime technologies of the Holmes Chapel manufacturing facility are metered-dose inhalers and nasal sprays.
Earlier this year, Recipharm completed a EUR 18 million ($22 million) investment to add a blow-fill-seal filling and packaging line, which is operational at its facility in Kaysersberg, France. The new blow-fill-seal high-speed filling and packaging line to the site takes the total number of lines to eight and increases the facility’s manufacturing capacity by 200 million unidoses/year.
Siegfried. As part of its new “Evolve” strategy, Siegfried, which provides both small-molecule API and drug-product (solid-dosage and sterile manufacturing/aseptic filling) development and manufacturing services, says it plans to grow within the value chain of its existing businesses by reaching critical size in the drug product sector and through backward integration. Siegfried plans to diversify into adjacent new businesses by enhancing its technology base in micronization, lyophilization, spray drying, and by adding additional high-potent manufacturing capabilities. Earlier this year (March 2018), Siegfried added to its drug-product manufacturing network with the acquisition from Arena Pharmaceuticals of a solid-dosage manufacturing facility in Zofingen, Switzerland.
Editor’s Note: This article was updated to include information on Avid Bioservices.